Supply update: Hormone Replacement Therapy medication Utrogestan®

22 May 2023 12:00 PM

A Serious Shortage Protocol (SSP) recently (19 May 2023) issued across the United Kingdom for Utrogestan® 100mg capsules. This will allow pharmacists to dispense a maximum of two months’ supply per prescription to help ensure continued access for women who use this popular medicine to help manage symptoms of the menopause.

• Decisive action will ensure women have continued access to Utrogestan® 100mg capsules
• New Serious Shortage Protocol (SSP) will limit amount a pharmacist can dispense to no more than two months’ supply
• Update issued to pharmacists to ensure uninterrupted supply of hormone replacement therapy (HRT) medication

Temporarily changing prescriptions of Utrogestan® to a maximum of two months’ supply will ensure more women can continue to access the medication they need.

Utrogestan®, a type of hormone replacement therapy (HRT) used to treat menopausal symptoms, is expected to be in intermittent supply until late 2023. Deliveries are frequently being made by the manufacturer, Besins, but it has struggled to meet rising demand. The manufacturer is taking steps to increase supply, but in the meantime the SSP will support access to available stock.

The department continues to monitor the HRT supply position very closely and work together with industry, the NHS and other key partners to help ensure the continuity of supply of HRT medicines across the UK for everyone that needs them.

Minister for the Women’s Health Strategy, Maria Caulfield recently said:

Today’s decisive action will mean more women will be able to access this medicine, and I want to reassure women that the vast majority of HRT products are in good supply.

The overall supply of HRT products has improved considerably over the last year and I am encouraged by how industry is responding to the growth in demand and our continued calls for action to boost supply to meet it.

We continue working to help ensure continuity of supply – which is a key part of increasing support for menopausal and pre-menopausal women and improving their quality of life.

Serious Shortage Protocols are a standard procedure, used frequently to manage temporary and potential medicine supply issues. They are a way to help ensure patients have access to safe and effective medicines, while saving time for patients, pharmacists and prescribers by allowing prescriptions to be issued without authorisation from the prescriber.

The government continues to take action to ensure women have access to vital menopause medication, including:

• Holding meetings with individual suppliers on a regular basis, requesting frequent stock updates, monitoring progress against plans, horizon scanning for upcoming issues, problem solving and expediting resupply dates, where needed to mitigate shortages, where possible;
• Hosting HRT supply roundtables with suppliers, wholesalers and community pharmacists, to provide updates on the supply position and actions being taken to address them, share data and discuss relevant policy developments and potential impacts;
• Issuing Serious Shortage Protocols for HRT products. Only 2 of the 22 issued since April last year remain, one for Progynova® 100microgram patches and a more recent one for Utrogestan®  100mg capsules, as the supply disruptions with most products experiencing shortages have been resolved;
• Adding some HRT medicines to the list of products that cannot be exported from, or hoarded in, the UK. Restrictions are used to support wholesalers to meet their legal obligation to supply the UK market, but only where less trade restrictive measures are not sufficient on their own;
• Sharing communications and comprehensive management guidance with the NHS on a regular basis, to provide advice on handling of supply issues, including direction to use alternatives where available.